The Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin Track Infection

NCT03756506 | Completed Results DMC FDA Device

• 1 other identifier: 2018-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate additional clinical uses for the polymer, which is a FDA approved, 510k, medical device, but has not been approved for use on patients with pin track sites as a way to lower the infection rate and is investigational for this purpose. The approved uses include wound care and post-operative care. About 13 subjects will take part in this study.

Conditions

Infection; Post-operative Care

Outcome Measures

Primary Outcomes (2)

• Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation

  Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.

  10 months

• Pin Track Infection Rate Among Research Participants Undergoing Deformity Correction and Traumatic Provisional Fixation

  Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.

  10 months

Study Arms (2)

Novel Microbicidal Liquid Polymer

ACTIVE COMPARATOR

All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply product with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. The Polymer will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.

Device: Novel Microbicidal Liquid Polymer

Control group: no Novel Microbicidal Liquid Polymer

NO INTERVENTION

The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver. Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills. Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.

Interventions

Novel Microbicidal Liquid Polymer DEVICE

The polymer is a 510K FDA cleared medical device indicated for providing a covering over minor wounds and scrapes that are clean and dry. The microbicidal liquid solution consists of organic polymers . The unique formulation eradicates any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the solvent's activity against an infinite number of organisms After eradication is complete, the solvent then transitions into a clear, elastomeric, non-odorous film for covering disrupted tissue. The film protects the wound against entry of water, dirt, and germs. The film is elastomeric and protects in difficult regions where flexing, bending and creasing skin occurs. The clear film forms in less than a minute.6 DuraDerm® should not be used to the treat deep infected wounds. DuraDerm® can be used to protect disrupted skin surface of wounds that are clean and dry.

Novel Microbicidal Liquid Polymer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Deformity correction, traumatic provisional fixation
• All pin sites are stable
• years of age or greater
• No known contraindication to receive product

You may not qualify if:

• Age less than 18 years
• Known allergy to Methylene Chloride
• Known sensitivity to organic polymers
• Non-clean, dry wound at pin
• Vulnerable research participants (Institutionalized, students, employees, prisoners, or those with decisional incapacity, etc.)

Sponsors & Collaborators

• Prevent-Plus LLC: lead

Study Sites (1)

Julie Morris

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Infections

Limitations and Caveats

This study is limited by its sample size when evaluating infection rate on a per patient basis.

Results Point of Contact

• Title: Jeff Elbl
• Organization: Prevent-Plus

jeff.elbl@prevent-plus.com

314-606-5046

Study Officials

• Shital Pema, DPM

  Kettering Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will enroll 12 total research participants (6 control research participants and 6 research participants) with approximately 120 pin sites (approximately 60 in the Control group and 60 in the DuraDerm® group). Each research participant undergoing Deformity Correction and/or Traumatic Provisional Surgery will be asked to participate in the study to evaluate if the topical application of a Novel Microbicidal Liquid Polymer as an additional step in the management of post-operative pin track site care reduces the incidence of pin track infections. Investigational Review Board (IRB) approval will be obtained and informed research participant consent will be obtained from each research participant.

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: November 7, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 30, 2021
• Results First Posted: July 13, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)